Pharma GMP News of the Week: 25-April-2023
Period: April 23, 2023 to May 20, 2023
Guidance from South Africa “Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH”
Date of news: Apr 24, 2023
This guideline is meant to offer suggestions to applicants who seek to submit both new and modified registration applications. It reflects the Authority’s current views on the security, effectiveness, and calibre of pharmaceuticals. It’s not meant to be a one-stop shop. In order to determine the safety, effectiveness, and quality of a medicine in accordance with the knowledge available at the time of review, SAHPRA maintains the right to seek any additional information. Alternative methods may be employed, but they must be supported scientifically and technically. The Authority is committed to ensuring that all registered medicines meet the necessary standards for quality, safety, and efficacy. To prevent delays in the processing and examination of applications, it is crucial that applicants follow the administrative procedures.
Source: quality and bioequivalence guideline | sahpra
MHRA updated guidance “Registration & Regulating Medical Devices in UK”
Date of news: Apr 27, 2023
The main reason for the change to this guidance was to reflect the intention to continue accepting CE-marked medical devices on the British market after 30 June 2023. This advice has been revised to reflect changes to the Reference Guides for “Labelling requirements,” “Regulation of medical devices in Northern Ireland,” “Summary of key requirements for placing a device on the Great Britain market,” “Registrations in Great Britain,” “UKCA marking,” “CE marking and Notified Bodies,” and “Lapping requirements.”
Source: Regulating medical devices in the UK – GOV.UK
EMA Guidance “Pre & Post Authorisation for Users of the Centralised Procedure”
Date of news: Apr 28, 2023
The European Medicines Agency has updated and published the guidelines on “Pre-authorization procedural advice for users of the centralised procedure” and “Post-authorization procedural advice for users of the centralised procedure” this week (25 April 20223).
Advice on the pre-authorization process for those using the centralised procedure
The purpose of the pre-authorization procedural advice is to help applicants prepare and submit marketing authorisation applications under the centralised system.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA and the European Commission will use the information in this guidance to evaluate the quality, safety, and efficacy of pharmaceuticals.
Source: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
News from EDQM “Requirements for the content of the CEP dossier according to the CEP 2.0 and updated application forms”
Date of news: April 28, 2023
beginning part of the CEP 2.0 deployment, some modifications to the content of CEP applications will be made, AND beginning of June 1, 2023, the usage of revised application forms will be required:
FDA published guidance “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products”
Date of news: May 01, 2023
The Food and Drug Administration (FDA or Agency) has just released a final industry guideline titled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.” The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) oversaw the development of the guidelines. For the conduct and general layout of nonclinical biodistribution (BD) studies for gene therapy (GT) products, the final guidance offers standardised suggestions. According to the 3Rs (reduce/refine/replace) principles, the guidelines in the guidance aim to make it easier to create experimental GT products while reducing needless animal exploitation. A draught of the guideline titled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products” that was released on September 9, 2021 has been replaced by the final guidance.
Source: https://www.fda.gov/media/167605/download
FDA published guidance “Study Data Technical Conformance Guide – Technical Specifications Document”
Date of news: May 01, 2023
The Food and Drug Administration (FDA)’s (FDA) current thinking on this subject is reflected in this set of technical requirements. It has no effect on the FDA or the general public and neither does it grant anyone any new rights. If an alternative strategy complies with the requirements of the relevant statutes and regulations, you may employ it. If you want to talk about a different strategy, get in touch with the FDA team that is responsible for putting this advice into action. Send an email to cder-edata@fda.hhs.gov or cber.cdisc@fda.hhs.gov if you are unable to locate the relevant FDA staff.
Source: https://www.fda.gov/media/153632/download
FDA published guidance “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products”
Date of news: May 01, 2023
The Food and Drug Administration (FDA or Agency) has released a final industry guideline document titled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.” The paper offers recommendations to help sponsors with the clinical development of nicotine replacement therapy (NRT) pharmacological products, including but not limited to those intended for chronic indications related to smoking cessation and others. This guideline completes the draught of the same-titled guidance that was released on February 22, 2019.
Source: https://www.fda.gov/media/167599/download
FDA published guidance “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022”
Date of news: May 01, 2023
The FDA User Fee Reauthorization Act of 2022’s Title I offers information to stakeholders about the EFDA’s implementation of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII). This guidance explains the changes made by the statute, which include changes to specific definitions, changes to specific PDUFA fee exceptions, waivers, exemptions, reductions, and returns2, as well as certain changes for PDUFA invoicing procedures, because PDUFA VII resulted in changes to the user fee programme.
Source: https://www.fda.gov/media/167877/download
MHRA Published three blog post on its website
Date of news: May 02, 2023
- MHRA Good Distribution Practice Symposium 2023
- MHRA Good Manufacturing Practice Symposium 2023
- ICH E6(R3) Good Clinical Practice guidance – Step 2 Public Consultation
Source: MHRA Inspectorate
FDA published guideline “Decentralized Clinical Trials for Drugs, Biological Products, and Devices”
Date of news: May 02, 2023
The decentralised clinical trials (DCTs) for pharmaceuticals, biological products, and devices should be implemented according to the guidelines provided in this draught guidance for sponsors, investigators, and other stakeholders. In this advice, a clinical trial is referred to as a DCT if some or all of the trial-related activities take place elsewhere other than the typical clinical trial venues.
Clinical trials that are completely decentralised conduct all of their operations apart from the usual trial venues. These trial-related events may occur at trial participants’ residences or in close-by medical centres that are convenient for trial participants. In hybrid DCTs, certain trial activities include trial participants visiting typical clinical trial sites in person, while other activities are carried out elsewhere, such at participants’ homes.
Source: https://www.fda.gov/media/167696/download
EMA published Interim Guidance “How to Approach the “PPD and CCI” while using CTIS”
Date of news: May 03, 2023
The goal of this guidance document is to help CTIS users use CTIS functionalities and understand the key guidelines for protecting personal information and business secrets when using CTIS and disseminating clinical trial information and materials.
The European Union’s Clinical Trials Information System (CTIS) is an IT platform that incorporates the EU portal and EU database that enables the interchange of clinical trials data within the EU.
Any information pertaining to an identified or recognisable natural person (the “data subject”) is referred to as personal data (PD).
Information submitted to CTIS that is not in the public domain or publicly accessible and whose publication could jeopardise the party’s legitimate economic interest or competitive position is referred to as commercially confidential information (CCI).
FDA published guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices”
Date of news: May 03, 2023
The decentralised clinical trials (DCTs) for pharmaceuticals, biological products, and devices should be implemented according to the guidelines provided in this draught guidance for sponsors, investigators, and other stakeholders. In this advice, a clinical trial is referred to as a DCT if some or all of the trial-related activities take place elsewhere other than the typical clinical trial venues. Clinical trials that are completely decentralised conduct all of their operations apart from the usual trial venues. These trial-related events may occur at trial participants’ residences or in close-by medical centres that are convenient for trial participants. In hybrid DCTs, certain trial activities include trial participants visiting typical clinical trial sites in person, while other activities are carried out elsewhere, such at participants’ homes.
Source: https://www.fda.gov/media/167696/download
FDA published guidance “Q9(R1) Quality Risk Management” on its website
Date of news: May 03, 2023
The Food and Drug Administration (FDA or Agency) has just released a final industry advice document titled “Q9(R1) Quality Risk Management.” The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) oversaw the development of the guidelines. The guidelines, which are a targeted revision of the industry’s “Q9 Quality Risk Management” guidance from 2006, address risks to product availability resulting from poor manufacturing quality, a lack of understanding of what formality in Quality Risk Management (QRM) work entails, a lack of clarity regarding risk-based decision-making, and a high degree of subjectivity in risk assessments and QRM outputs. The revision aims to offer guidance on quality risk management practises and instruments that can be utilised in various pharmaceutical quality.
Source: https://www.fda.gov/media/167721/download
Guidance from Swiss Medic “Transfer of Marketing Authorisation”
Date of news: May 03, 2023
The guidelines in this document outline the prerequisites and requirements (together with the required supporting documentation) for submitting an application to transfer authorizations for human and animal medical products.
Swissmedic released the guideline document to make clear the specifications that must be fulfilled in accordance with its practise.
This guideline paper is applicable to requests in the Infrastructure, Authorization, and Market Surveillance divisions for the transfer of marketing authorizations to new marketing authorization holders.
In addition, the advice document offers details on the application deadline, the transfer fees, the repercussions of the transfer, and the supporting documentation needed to complete the application. The advice document also explains the duties of the new owner, including assuring the efficacy, safety, and quality of the product.
Source: Guidance document – Transfer of marketing authorisation
News from EDQM “Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and components”
Date of news: May 05, 2023
The European Pharmacopoeia Commission (EPC) decided to develop three new general texts addressing issues linked to the development and control of mRNA vaccines and their components as a way to help this developing sector at its 175th session in March 2023.
Guidance from South Africa’s SAPHRA “Validation Template For ECTD Variation Applications, QOA & QIS”
Date of news: May 05, 2023
How to validate electronic submissions of variation applications for human pharmaceuticals in South Africa is explained in SAPHRA’s Validation Template For ECTD Variation Applications.
When assessing a modification application submitted in eCTD format for a medicinal product for human use, SAHPRA can confirm that all necessary information has been given by using the application’s validation template. The validation criteria, the validation procedure, the validation report, and the validation checklist are all included in this section.
The applicant must make sure that all pertinent areas are filled out because it is also utilised for follow-up sequences that may be necessary for the variant.
The deadline for implementation is May 15, 2023.
Source: VALIDATION TEMPLATE FOR eCTD VARIATION APPLICATIONS
Guidance from Ireland’s HPRA “Guidance on Reporting & Investigation of Quality Defects”
Date of news: May 2023
One of the main goals of this guidance is to offer stakeholders with extra guidance beyond that found in the legislation so that stakeholders
(i) To reduce the danger to people or animals, properly report and investigate any suspected quality flaws within the necessary timeframes.
Apply the necessary monitoring to defect concerns in accordance with the degree of risk posed (ii).
(iii) Conduct thorough root cause analysis (RCA) investigations to make sure the proper corrective and preventive measures are put in place, to stop the issues that caused the quality fault from happening again.
This manual outlines the procedures for examining and informing the HPRA of quality issues with human and veterinary pharmaceuticals.
Guideline from EC MDCG “Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR”
Date of news: May 2023
This guidance document aims to define “significant changes in the design and intended purpose” as defined by MDR Article 120(3c), Point (b).
In the European Union (EU), the term “legacy device” refers to a medical device that was lawfully marketed before the Medical Devices Regulation (MDR) took effect.
There must be a change in the design or intended purpose in addition to the change being significant for there to be a significant change in the design or intended purpose.
It is the manufacturer’s duty to demonstrate and justify changes so that they do not affect the device’s intended function or design, or, if they do, that they are minor and should be evaluated individually.
Source: https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf
FDA published guidance “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol”
Date of news: May 08, 2023
The purpose of this recommendation is to warn glycerin and other high-risk medication components contaminated with diethylene glycol (DEG) or ethylene glycol (EG) about the potential public health danger they pose. The FDA has received and is still receiving reports (most recently in early 2023) of fatal poisonings of users of liquid dosage drug products (such as cough, allergy, analgesic, and antiemetic medicine products) that were produced with DEG- or EG-contaminated components.
Source: https://www.fda.gov/media/167974/download
FDA published guidance “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”
Date of news: May 11, 2023
In order to offer suggestions for determining donor eligibility using specific risk-based questions, the FDA is providing this guidance. The FDA’s updated donor deferral recommendations for those with a higher risk of transmitting human immunodeficiency virus (HIV) infection are provided to you, blood establishments that collect blood or blood components, including Source Plasma. We also advise that you update your donor requalification and product management procedures in accordance with the changes you make to your donor education materials, donor history questionnaires, and supporting materials.
Source: https://www.fda.gov/media/164829/download
FDA published guidance “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components”
Date of news: May 11, 2023
The standardised full-length and condensed donor history questionnaires and related materials, version 4.0 dated May 2023, created by the AABB Donor History Task Force, are recognised as suitable in this guidance. In accordance with Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12), this guideline also offers recommendations to licenced establishments on how to report implementation of the appropriate AABB donor history questionnaires and related materials (DHQ papers).
Source: https://www.fda.gov/media/124193/download
Guideline from UK MHRA “Guidance on Qualified Person responsible for QPPV & PSMF”
Date of news: May 11, 2023
The previous section, “Notification of QPPV and PSMF details to the MHRA by existing holders of UK marketing authorisations,” has been changed with new instructions. The former requirement to submit a Type IA(IN) variation and an associated eCTD sequence to make these changes has been replaced by this guidance. There is no longer a need to submit an eCTD sequence; instead, simply an update notification is needed.
Guideline from UK MHRA “Notifying MHRA on a Clinical Investigation for a Medical Device”
Date of news: May 11, 2023
The maker or sponsor may be required to carry out a clinical investigation in order for your medical device to receive a UKCA / CE / CE UKNI label. You must also give the MHRA sixty days’ notice if you intend to conduct an investigation.
Medical equipment that are UKCA, CE, or CE UKNI marked for the use that is being investigated won’t need to be notified to the MHRA.
The regulatory staff at MHRA will evaluate the application against the Validation Checklist- GB New Submissions when it is received for a clinical research of a medical device. This checklist will assist in submitting a legitimate application.
Source: Notify the MHRA about a clinical investigation for a medical device – GOV.UK
Guideline from EMA “Good Practices for Industry for the Prevention of Human Medicinal Product Shortages”
Date of news: May 17, 2023
The European Medicines Regulatory Network (EMRN) and other international agencies acknowledge that there is an international issue with pharmaceutical shortages. European nations have experienced an increase in shortages throughout time, which has had a significant influence on patient treatment.
In accordance with this document, marketing authorization holders, distributors, wholesalers, and manufacturers are urged to implement best practises for preventing shortages in human medication, such as lowering the likelihood that shortages may emerge in the first place. Also offered are suggestions for minimising a scarcity occurrence.
To guarantee the continuity of drug supply, this guidance includes topics including supply chain management, risk assessment, communication, and contingency planning. The advice aims to encourage industry cooperation and proactive actions to reduce the effects of shortages and assure the availability of necessary medicines for patients.
Source: Good practices for industry for the prevention of human medicinal product shortages
Guideline from MHRA ‘Med Dev Guidance on “Off-Label Use”,”Virtual Mfg.” “Legal Requirements” & “Approved Bodies”’
Date of news: May 16, 17, 2023
This week (16–17 May 2023) the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) amended a number of guidances pertaining to medical devices.
Source:
- Guidance on “Medical Devices: Software Applications (apps)“
- Guidance on “Virtual manufacturing of medical devices“
- Guidance on “Medical devices: Legal Requirements for Specific Medical Products“
- Guidance on “Medical devices: Off-Label Use“
- Guidance on “Approved Bodies for Medical Devices“
Guidance on “Medical Devices: Software Applications (apps)”
Guidance from USFDA “Pediatric Drug Development – Regulatory and Scientific Considerations”
Date of news: May 18, 2023
On 18-May-2023, the US Food & Drug Administration published two draft guidelines, “Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” and “Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations“.
Source:
1. Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for P
